Advisory Council on Blood Stem Cell Transplantation
Advisory Council’s official designation
The Advisory Council shall be known as the Advisory Council on Blood Stem Cell Transplantation (ACBSCT or Advisory Council).
Authority
ACBSCT is required by Public Law 109-129, as amended. The Advisory Council is governed by provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. 10), as amended.
Objectives and scope of activities
ACBSCT shall advise, assist, consult with, and make recommendations to the Secretary of Health and Human Services (Secretary) on matters related to the C.W. Bill Young Cell Transplantation Program (Program) and National Cord Blood Inventory (NCBI). ACBSCT may transmit its recommendations through the Administrator of the Health Resources and Services Administration (HRSA) on matters related to the activities of the Program and NCBI. The principal purpose of these programs is to increase the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood. The recommendations of the Advisory Council assist the Department of Health and Human Services in overseeing these programs. The statute also requires ACBSCT's involvement in submitting reports to Congress.
Description of duties
ACBSCT shall, as requested by the Secretary, discuss and make recommendations regarding the Program or NCBI. Other duties may include the following:
- Providing a consolidated, comprehensive source of expert, unbiased analysis, and recommendations to the Secretary on the latest advances in the science of blood stem cell transplantation and donation;
- Assisting with the development of policies affecting the Program or NCBI; and
- Reviewing the state of the science of using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the Program.
Agency or federal official receiving the committee's advice/recommendations
ACBSCT provides advice and recommendations to the Secretary. ACBSCT may transmit its recommendations through the HRSA Administrator on matters related to the activities of the Program and NCBI.
Support
Management and support services are provided by the Health Systems Bureau of HRSA.
Estimated annual operating costs and staff years
The fiscal year 2025 estimated annual cost for operating ACBSCT, including compensation and travel expenses for members but excluding staff support, is $146,090. Estimated staff support required is 0.55 full-time equivalent years at an estimated annual cost of $134,059.
Designated federal officer (DFO)
A full-time federal employee, appointed in accordance with agency procedure, will serve as the DFO and ensure that all procedures are within applicable statutory, regulatory, and the Department of Health and Human Services General Administration Manual directives. The DFO approves and prepares all meeting agendas, calls all Advisory Committee or subcommittee meetings, attends all ACBSCT and subcommittee meetings, adjourns any meeting when the DFO determines adjournment to be in the public interest, and chairs meetings when directed to do so by the HRSA Administrator.
Estimated number and frequency of meetings
ACBSCT shall meet at least two times each calendar year. Each meeting must be called or approved by the DFO. Quorum is defined as a majority of the appointed members. Meetings shall be open to the public except as determined otherwise by the Secretary or d signee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act of 1972 (5 U.S.C. 10). Notice of all meetings shall be given to the public. Meetings shall be conducted, and records of the proceedings kept, as required by applicable laws and departmental regulations.
Duration
Continuing
Termination
Unless renewed by appropriate action prior to its expiration, ACBSCT charter will terminate 2 years from the date the charter is filed.
Membership and designation
The Advisory Council shall consist of up to 15 members, who are Special Government Employees, and four ex-officio, non-voting members. Members and the Chair shall be appointed by the Secretary to ensure objectivity and balance and reduce the potential for conflicts of interest. The Secretary shall establish bylaws and procedures to prohibit any member of the Advisory Council who has employment, governance, or financial affiliation with a donor center, recruitment organization, transplant center, or cord blood bank from participating in any decision that materially affects the center, recruitment organization, transplant center, or cord blood bank and to limit the number of members of the Advisory Council with any such affiliation.
Concurrent service on the Advisory Council and the Board of Directors, or other governing body, of organizations who hold a contract for the Program, is not permitted. To the extent practicable, committee Special Government Employees should represent those served by the Program.
The members and Chair shall be appointed by the Secretary from outstanding authorities and representatives of marrow donor centers and marrow transplant centers; representatives of cord blood banks and participating birthing hospitals; recipients of a bone marrow transplant; recipients of a cord blood transplant; persons who require such transplants; family members of such a recipient or family members of a patient who has requested the assistance of the Program in searching for an unrelated donor of bone marrow or cord blood; persons with expertise in bone marrow and cord blood transplantation; persons with expertise in typing, matching, and transplant outcome data analysis; persons with expertise in the social sciences; basic scientists with expertise in the biology of adult stem cells; ethicists, hematology and transfusion medicine researchers with expertise in adult blood stem cells; persons with expertise in cord blood processing; and members of the public.
The Advisory Council also includes as non-voting, ex-officio members, representatives from the Division of Transplantation of HRSA, the Department of Defense Marrow Recruitment and Research Program operated by the Department of the Navy, the Food and Drug Administration, and the National Institutes of Health.
Special Government Employees shall be invited to serve for a term of 2 years, and each such member may serve as many as three consecutive 2-year terms, except that such limitations shall not apply to the Chair of the Advisory Council (or the Chair-elect) or to the member of the Advisory Council who most recently served as the Chair; and one additional consecutive 2-year term may be served by any member of the Advisory Council who has no employment, governance, or financial affiliation with any donor center, recruitment organization, transplant center, or cord blood bank. A member of the Advisory Council may continue to serve after the expiration of the term of such member until a successor is appointed. To ensure the continuity of the Advisory Council, the Advisory Council shall be appointed so that each year the terms of approximately one-third of the members of the Advisory Council expire. Any member of the Advisory Council who has employment, governance, or financial affiliation with a donor center, recruitment organization, transplant center, or cord blood bank will be prohibited from participating in any decision that materially affects the donor center, recruitment organization, transplant center, or cord blood bank. The number of members with such affiliations on the Advisory Council shall be limited.
Subcommittees
Standing and ad hoc subcommittees, composed of members of the parent Advisory Council, may be established with the approval of the DFO to perform specific functions within ACBSCT jurisdiction. Subcommittees must report back to the parent Committee and do not provide advice or work products directly to the Department of Health and Human Services or HRSA. The Department's Committee Management Officer will be notified upon the establishment of each subcommittee and will be provided information on the subcommittee's name, membership, function, and estimated frequency of meetings.
Recordkeeping
Records of the Advisory Council, formally and informally established subcommittees, or other subgroups of the Advisory Council, shall be handled in accordance with General Records Schedule 6.2, or other approved agency records disposition schedule. These records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.
Filing date
February 19, 2025
Approved
February 19, 2025
/s/ Thomas J. Engels
Administrator, Health Resources and Services Administration
Download
Download the charter (PDF - 680 KB)